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Not yet recruiting NCT06662370

Esophageal Replacement With a Decellularized Human Esophagus Graft

Phase I / Phase II Interventional Esophageal Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Replacement of the esophagus with a decellularized human esophagus graft.
Who it may be relevant to
Registry conditions: Esophageal Stenosis. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Remplacement de l'œsophage Par Une Greffe d'œsophage Humain décellularisé

Overview

The aim of the study is to analyze over a 12 month-period, the safety and the efficacy of a circumferentiel oesophageal replacement of the esophagus by a decelularized human esophagus, in 24 patient with a short esophageal stenosis refractory to endoscopic dilatations.

Interventions

  • Other Replacement of the esophagus with a decellularized human esophagus graft
    The Decellularized Human Esophagus (DHE) will be surgically implanted under general anesthesia via right or left thoracotomy or cervicotomy, depending on the location of the stenosis, to replace the esophageal defect created by resection of the stenosis. An omentoplasty is performed laparoscopically beforehand to provide secondary coverage of the graft area. A temporary esophageal stent is placed endoscopically to cover the DHE and the two anastomoses for a period of 3 months, to prevent the dev

Primary outcome measures

  • Morbidity/mortality [Time frame: At 3 months after surgery]
  • Nutritional autonomy [Time frame: At 12 months after esophageal replacement]
Secondary outcome measures (12)
  • Safety of the procedure [Time frame: At 12 months after esophageal replacement]
  • Presence of complete re-epithelialization, and integration into the native esophagus [Time frame: At 3 months after surgery]
  • Presence of complete re-epithelialization, and integration into the native esophagus [Time frame: At 12 months after surgery]
  • Normal bolus transit [Time frame: At 6 months after surgery]
  • Normal bolus transit [Time frame: At 12 months after surgery]
  • Esophageal manometry [Time frame: At 12 months after surgery]
  • Percentage of procedures interrupted for logistical reasons [Time frame: Up to 14 months]
  • Overall survival and Safety of procedure [Time frame: At 12 months after surgery]
  • Impact of procedure on quality of life [Time frame: At 6 months after surgery]
  • Impact of procedure on quality of life [Time frame: At 12 months after surgery]
  • Impact of procedure on quality of life [Time frame: At 6 months after surgery]
  • Impact of procedure on quality of life [Time frame: At 12 months after surgery]

Eligibility criteria

Inclusion criteria

  • Age: 18 to 65
  • Caustic, traumatic, anastomotic, post-operative, radiation-induced or post-endoscopic (mucosal resection, submucosal dissection) benign esophageal stricture refractory to endoscopic dilatation.
  • For women: effective contraception for the entire duration of the study (from signature of consent to end of follow-up)
  • Affiliated or beneficiary of a social security scheme.
  • Free written consent signed by the participant and the investigator.

Exclusion criteria

  • Weight loss > 10% of body weight over last 3 months
  • Stenosis > 5 cm in length
  • Multiple strictures
  • Esophageal mouth stenosis
  • Anterior surgery close to the operative zone
  • Complete anterior omentectomy
  • Tumour stenosis or progressive tumour pathology
  • Non-stabilized psychiatric disorders
  • Participation in another interventional study
  • Pregnant or breast-feeding women
  • Women of childbearing age without effective contraceptive measures:

All women of childbearing age must have a negative pregnancy test prior to treatment and must agree to maintain highly effective contraception using contraceptive measures from the date of consent until 12 months due to the risks associated with anesthesia during endoscopy

  • Uncontrolled sepsis
  • Related to the transplant procedure
  • ASA score ≥ 3,
  • Severe respiratory insufficiency (FEV1 < 1 L),
  • Decompensated hepatic cirrhosis or presence of esophageal varices,
  • Chronic renal insufficiency (creatinine > 1.25 N),
  • Myocardial infarction less than 6 months old or progressive heart disease,
  • WHO general condition > 2,
  • Weight loss >20% not recovered after renutrition.
  • Contraindication to general anaesthesia, analgesics and antibiotics.
  • Conditions requiring long-term immunosuppressive or corticosteroid treatment.
  • Patients under curatorship or guardianship

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06662370 · APHP220793

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗